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Infusion of Specially Treated Umbilical Cord Stem Cells After Chemoradiation Treatment for Blood Cancers

This study has been completed.
Sponsor:
Information provided by:
ViaCell
ClinicalTrials.gov Identifier:
NCT00089596
First received: August 6, 2004
Last updated: April 11, 2007
Last verified: April 2007
History of Changes
  Purpose

This study hopes to show that specially treated umbilical cord cells, called stem cells, can be safely given to a person after they receive chemoradiation therapy or chemotherapy for their illness. During chemoradiation therapy or chemotherapy, a person loses all of the cells that are needed to make the different types of cells in their blood, including their immune system cells. These cells must be replaced in order for the blood and immune systems to work properly. Some people receive bone marrow transplants or other types of stem cell transplants to get the cells they need. CB001 is being developed as an option for people who need bone marrow transplants or other types of transplants to replace those cells. It is also being developed for people who do not have the option of other types of transplants.


Condition Intervention Phase
Acute Lymphocytic Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Non-Hodgkin Lymphoma
Chronic Myelogenous Leukemia
 Procedure: Expansion of umbilical cord stem cells
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Safety Study of Infusion of Ex Vivo Selectively Amplified Unrelated Cord Blood Stem Cells in Subjects With Hematological Malignancies Receiving Unrelated Cord Blood Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ViaCell:

Estimated Enrollment: 10
Study Start Date: March 2004
Estimated Study Completion Date: October 2006
  Eligibility

Ages Eligible for Study:   12 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Do not have identical or 5/6 related matched bone marrow, peripheral blood or umbilical cord
  • Stable disease and lack of unrelated donor
  • Acute myeloid leukemia (AML) in 2nd or subsequent complete remission or first remission with high risk features
  • ALL in 2nd or subsequent remission or first remission with high risk features
  • Myelodysplastic syndrome (MDS)
  • Non-Hodgkin Lymphoma (NHL)
  • Chronic Myelogenous Leukemia (CML)
  • Adequate function of heart, liver, kidneys and lungs

Exclusion Criteria:

  • Females who are pregnant
  • Poor ability to perform daily activities
  • Weight under 40 kilograms (88 pounds)
  • AML caused by chemoradiation
  • Prior stem cell transplant
  • Uncontrolled infection at time of transplant
  • Active fungal infection
  • HIV infection
  • Primary myelofibrosis
  • Receiving other research drugs
  • Unable to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089596

Locations
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
ViaCell
Investigators
Study Director: Kurt Gunter, MD ViaCell
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00089596     History of Changes
Obsolete Identifiers: NCT00301704
Other Study ID Numbers: CB001
Study First Received: August 6, 2004
Last Updated: April 11, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by ViaCell:
umbilical cord blood
transplant
ALL
AML
 MDS
NHL
CML

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma
Lymphoma, Non-Hodgkin
Myelodysplastic Syndromes
Preleukemia
 Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on June 18, 2013